Bio-Rad Laboratories, Inc. recalls CMV IgM EIA, in vitro diagnostic.

Recalled December 7, 2022 · FDA recall Z-0342-2023 · Bio-Rad Laboratories

Hazard

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). · FDA Class II

Units

180 kits

Sold at

U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None

Description

Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).

Product

CMV IgM EIA, in vitro diagnostic.

Manufacturer(s)

Bio-Rad Laboratories, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →